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临床试验/NCT06773325
NCT06773325已完成不适用

The Effect of Buzzy Application on Pain and Comfort Level During Heel Blood Collection in Newborns: A Randomized Controlled Study

Yuzuncu Yıl University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
The Neonatal Infant Pain Scale

研究概览

简要总结

Objective The aim of this study was to evaluate the effects of Buzzy device application during heel prick blood collection on pain level and comfort in newborns.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between September and November 2024 using a randomized controlled experimental design. The study sample consisted of 80 newborn infants born at 37-42 weeks gestational age and within the first 28 days of birth (Buzzy group: n = 40, control group: n = 40). The Buzzy group was treated by placing the Buzzy device approximately 30 seconds before heel prick blood collection. In the control group, routine heel prick was performed without any application. Neonatal introduction form, Neonatal Infant Pain Scale and Neonatal Comfort Behavior Scale were used for data collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
0 Days 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Those in the neonatal period between 0-28 days,
  • voluntary participation of the parent,
  • between 37-42 weeks of gestational age
  • babies with vital signs within normal limits

排除标准

  • The integrity of the skin in the area where the device was to be implanted was compromised,
  • Nerve damage or deformity in the extremity to be heel bled,
  • Genetic - with a congenital anomaly or congenital metabolic disorder,
  • undergoing cardiopulmonary resuscitation,
  • No heel prick on the first attempt,
  • with osteogenesis imperfecta and infants given analgesics in the last 6 hours

结局指标

主要结局

The Neonatal Infant Pain Scale

时间窗: pre-test post-test (approximately three months)

min-max (0-7) , fewer points is a good result

次要结局

未报告次要终点

研究者

发起方
Yuzuncu Yıl University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veysel Can

Asst. Prof.

Yuzuncu Yıl University

研究点 (2)

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